Ball Burn M-1 (titanium Nitr)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref AEBM1TN

by American Eagle Instruments

Identity

Trade Name: BALL BURN M-1 (TITANIUM NITR) EUDAMED
American Eagle Instruments FDA UDI
Generic Name: Manual dental burnisher, reusable FDA UDI
Device Name: Burnisher EUDAMED
BALL BURN M-1 (TITANIUM NITR FDA UDI
Model / Reference: AEBM1TN EUDAMEDFDA UDI
Description: BALL BURN M-1 (TITANIUM NITR FDA UDI

Identifiers

Catalog Number: AEBM1TN FDA UDI
Primary DI / UDI-DI: 00841013102059 EUDAMEDFDA UDI
Basic UDI-DI: 0841013164078EKKD169678HL EUDAMED
FDA Product Code: EKK FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Manual dental burnisher, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.4565 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental appliance fabrication material, ceramic

Ball Burn M-1 (titanium Nitr) by American Eagle Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0841013164078EKKD169678HL	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: American Eagle Instruments
EUDAMED SRN: US-MF-000018222
Authorised Representative: Young Microbrush Ireland Ltd IE-AR-000011249

Sources (2)

EUDAMED 4f1a28ed-cd4a-4b39-9286-0b448f9acd9a 61 fields · synced Jul 22, 2026
FDA UDI 9a1f32e9-b714-4561-a0ca-e59ebaa73ce7 35 fields · synced May 30, 2026